UMIN-CTR Clinical Trial

Basic information
Public title	Continuos effect of general anesthesia and positive end-expiratory pressure on functional residual capacity during peri-operation.
Acronym	Continous effect of anesthesia and PEEP on FRC
Scientific Title	Continuos effect of general anesthesia and positive end-expiratory pressure on functional residual capacity during peri-operation.
Scientific Title:Acronym	Continous effect of anesthesia and PEEP on FRC
Region	Japan

Condition
Condition	general anesthetized patients
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Oto-rhino-laryngology Orthopedics Urology Neurosurgery Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of PEEP and PEEP timing on FRC and oxygenation during peri-operation. Continuous measuring of FRC.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Study of proper PEEP level by FRC during peri-operative period and effect of PEEP on prognosis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	respirator
Interventions/Control_2	level of PEEP
Interventions/Control_3	PEEP timing
Interventions/Control_4	FRC
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	not particular
Key exclusion criteria	Chronic obstructive pulmonary disease
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Daizoh Middle name Last name Satoh
Organization	Tohoku university postgraduate medical school
Division name	department of anesthesia and perioperative medicine
Zip code	980-8574
Address	2-1 Seiryomachi, Aoba-ku, Sendai
TEL	022-717-7321
Email	ds0226@fsinet.or.jp

Public contact
Name of contact person	1st name Daizoh Middle name Last name atoh
Organization	Tohoku university postgraduate medical school
Division name	department of anesthesia and perioperative medicine
Zip code	980-8574
Address	2-1 Seiryomachi, Aoba-ku, Sendai
TEL	022-717-7321
Homepage URL
Email	se803714@fsinet.or.jp

Sponsor
Institute	department of anesthesia and perioperative medicine Tohoku university postgraduate medical school
Institute
Department

Funding Source
Organization	department of anesthesia and perioperative medicine Tohoku university postgraduate medical school
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	NONE
Name of secondary funder(s)	NONE

IRB Contact (For public release)
Organization	the Ehics committee of Tohoku University Hospital
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
Tel	022-717-7319
Email	ec*rinri.hosp.tohoku.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2008 Year 11 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2008 Year 11 Month 19 Day
Date of IRB	2008 Year 12 Month 01 Day
Anticipated trial start date	2008 Year 12 Month 01 Day
Last follow-up date	2011 Year 12 Month 01 Day
Date of closure to data entry	2011 Year 12 Month 01 Day
Date trial data considered complete	2011 Year 12 Month 01 Day
Date analysis concluded	2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2008 Year 11 Month 19 Day
Last modified on	2019 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001826